Who is this blogger?
Annet Muetstege - Visscher
My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
Location and time zone
All content on this blog is subject to a Creative Commons Licence
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Recent Posts
- CORONAVIRUS AND CLINICAL STUDIES: WHAT TO DO?
- 2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS
- EU MDR DEADLINE MAY 2020: CLINICAL EVIDENCE STATE OF AFFAIRS AT YEAR’S END
- 6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
- INCREASED CLINICAL EVIDENCE DEMANDS FOR MEDICAL DEVICES IN EU: MORE OR BETTER?
Latest Tweets
- For anyone involved in medical devices. Mind you “just a proposal, no law yet". #medicaldevice #mdr lnkd.in/eV6BBsc 8 hours ago
- Commission postpones application of the MDR. #mdr #medicaldevice lnkd.in/e9-Tf-c 1 day ago
- FDA updates guidance on clinical trial conduct during Covid-19 pandemic. #clinicaltrial #coronavirus #covid… twitter.com/i/web/status/1… 5 days ago
- EU Commission working on a proposal to delay the MDR date of application by one year. Use that time well to collect… twitter.com/i/web/status/1… 1 week ago
- CEN & CENELEC in cooperation with the EU, temporarily providing a number of EU standards related to personal protec… twitter.com/i/web/status/1… 1 week ago
Most used tags
- Adverse Event handling
- Clinical benefit
- clinical evaluation
- Clinical Evidence
- Clinical Evidence Plan
- Clinical Investigation
- Clinical Research
- clinical studies
- Clinical Study Population
- Clinical Trial
- Clinical Trial Investment
- clinicaltrials gov
- Controlled Clinical Trial
- Cost Effective
- Country Regulations
- Data-management
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- Informed Decisions
- investigator-sponsor
- ISO 14155
- IVDR
- Market Access
- Market adoption
- MDCG guidances
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- medical device industry
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- PMCF
- Post-market Observational Study
- Postmarket Clinical Follow-Up
- Postmarket Safet Reporting
- Postmarket Safety Reporting
- Postmarket Studies
- Postmarket Surveillance
- Premarket Safety Reporting
- Premarket Study
- Product Claims
- Publication
- Publication Bias
- Publication Strategy
- Randomized Clinical Trial
- Registry
- Reimbursement
- remote monitoring
- risk-based monitoring
- science
- Scientific Credibility
- Site Monitoring
- Sponsor
- Vigilance
Tag Archives: Market adoption
PUBLISH OR PERISH
Although retractions may sometimes suggest otherwise, publication of clinical data is how to obtain the return on a clinical trial investment. The clinical trial investment is substantial as the process to collect clinical evidence from research sites is involved and … Continue reading
Posted in Uncategorized
Tagged Clinical Evidence Plan, Clinical Trial, Clinical Trial Investment, clinicaltrials gov, Informed Decisions, Market Access, Market adoption, medical device industry, Medical Devices, Patient Outcomes, Publication, Publication Bias, Publication Strategy, science, Scientific Credibility
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